Prescription drug · NDA
BYNFEZIA Pen (Octreotide acetate) NDC 62756-452
Octreotide acetate 2.5 mg/mL · Injection · Subcutaneous · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62756-452-36 | 62756045236 | 1 CARTRIDGE in 1 CARTON (62756-452-36) / 2.8 mL in 1 CARTRIDGEMarketed from Feb 24, 2025 | |
| 62756-452-37 | 62756045237 | 2 CARTRIDGE in 1 CARTON (62756-452-37) / 2.8 mL in 1 CARTRIDGEMarketed from Feb 24, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- BYNFEZIA Pen
- Generic name (nonproprietary)
- octreotide acetate
- Active ingredients
- Octreotide acetate — 2.5 mg/mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 62756
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213224
- Marketing start
- Listing expires
- Other FDA classes
- Somatostatin Receptor Agonists (Mechanism)
- Identifiers
- Product ID 62756-452_ee3c8bae-88f0-4b76-80af-98a3e3312585SPL ID ee3c8bae-88f0-4b76-80af-98a3e3312585SPL set ID 20ed4e79-ad4c-426f-859d-83790c00439bRxCUI 2360543, 2360548UNII 75R0U2568I
- Pharmacologic class
- Somatostatin Analog
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N462756045236followed by a unit qualifier and the quantityPackage 62756-0452-36. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
BYNFEZIA PEN is a s o matostatin analogue indicated: Acromegaly : To reduce blood levels of growth hormone (GH) and insulin growth factor 1 (IGF-1; somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. (1 .1) Carcinoid Tumors : For the symptomatic treatment of patients with m eta static c a rcinoid t u mo rs where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease. (1 .2) Vasoactive Intestinal Peptide Tumors (VIPomas) : For the treatment of profuse watery diarrhea associated with VIP-secreting tumors . (…
Excerpt only. Read the full label for complete information.
About NDC 62756-452
- What is NDC 62756-452?
- 62756-452 is the product NDC for BYNFEZIA Pen (octreotide acetate), Octreotide acetate 2.5 mg/mL injection, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- BYNFEZIA Pen (Octreotide acetate).
- What is the active ingredient?
- Octreotide acetate.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 62756. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for BYNFEZIA Pen?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.